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Clinical Trial News

SINTX Technologies Submits FDA 510(k) for Silicon Nitride Foot and Ankle Implants

  • SINTX Technologies has submitted a 510(k) premarket notification to the FDA for silicon nitride osteotomy wedges, marking the company's entry into the foot and ankle reconstruction market.
  • The implants are manufactured from proprietary medical-grade silicon nitride, which has demonstrated pro-osteogenic properties, antimicrobial activity, and superior radiographic clarity compared to traditional materials like PEEK and titanium.
  • The devices leverage over a decade of clinical experience with silicon nitride, including more than 50,000 spinal interbody fusion devices implanted since 2008.
  • The foot and ankle fusion market is valued at approximately $750.5 million and is expected to grow to $1.38 billion by 2032, representing a significant commercial opportunity for SINTX.

Radiopharm Theranostics Appoints Leading Prostate Cancer Expert Dr. Oliver Sartor to Scientific Advisory Board

Oncology
  • Radiopharm Theranostics has appointed Dr. Oliver Sartor, an internationally recognized medical oncologist specializing in prostate cancer and radiopharmaceutical therapies, to its Scientific Advisory Board.
  • Dr. Sartor currently serves as Director of Radiopharmaceutical Clinical Trials at Mayo Clinic and has led multiple pivotal Phase 3 trials resulting in FDA approvals for radiopharmaceutical therapies.
  • The appointment strengthens Radiopharm's clinical expertise as the company advances its radiopharmaceutical pipeline, which includes one Phase 2 and three Phase 1 trials across various solid tumor cancers.

BioVie Strengthens Board with Neuroscience and Finance Veterans as Bezisterim Advances Through Phase 2 Trials

  • BioVie Inc. appointed Amy S. Chappell, MD, FAAN, and Kameel D. Farag to its Board of Directors to support the company's neurological and liver disease drug development programs.
  • Dr. Chappell brings 25 years of CNS drug development experience at Eli Lilly, including FDA approvals for Cymbalta in fibromyalgia and musculoskeletal pain indications.
  • The appointments coincide with BioVie's ongoing Phase 2 trials of bezisterim for early Parkinson's disease and long COVID, plus advancing Alzheimer's disease and liver cirrhosis programs.
  • Farag's financial expertise includes securing over $150 million in financing at Aspen Neuroscience and scaling operations at major pharmaceutical companies like Ionis and Amgen.

A Phase 3 Study of NE3107 in Probable Alzheimer's Disease

NCT04669028CompletedPhase 3
BioVie Inc.
Posted 8/5/2021

Insulin-Sensitizing Anti-Inflammatory Small Molecule for Investigative Treatment of Dementia

NCT05227820CompletedPhase 2
Neurological Associates of West Los Angeles
Posted 1/19/2022

NE3107 Activity and Safety in Patients With Parkinson's Disease Using Levodopa

NCT05083260CompletedPhase 1
BioVie Inc.
Posted 1/4/2022

CGT Catapult Invests in Spliceor's Trans-Splicing Gene Therapy Platform for Liver Cancer

Oncology
  • The Cell and Gene Therapy Catapult made its first investment through the Cross-Catapult Investment Pilot in Spliceor, a Cambridge University spinout developing trans-splicing gene therapy for liver cancer.
  • Spliceor's platform targets hepatocellular carcinoma, which has a five-year survival rate of just 13.4% and affects approximately 6,500 new patients annually in the UK.
  • The funding will support pre-clinical development and team expansion as Spliceor advances its precise gene repair technology toward clinical trials.
  • This investment represents a new UK initiative supported by Innovate UK to strengthen the advanced therapies pipeline through targeted seed investments in early-stage companies.

IXICO Secures Full Data Rights to Landmark Bio-Hermes-002 Alzheimer's Study Through Strategic GAP Partnership

  • IXICO has deepened its collaboration with the Global Alzheimer's Platform Foundation through an agreement securing full data usage rights to the Bio-Hermes-002 study, one of the most prominent global studies in Alzheimer's disease research.
  • The partnership enables IXICO to accelerate its vascular biomarker analysis R&D program in Alzheimer's disease and adjacent neurodegenerative diseases while extending its product offering to support blood-based biomarker market approval.
  • Bio-Hermes-002 compares blood-based and digital biomarkers across diverse clinical cognitive conditions to generate data that may help predict, detect and diagnose Alzheimer's disease and related dementias.
  • The study aims to enhance understanding of newly identified AD biomarkers and advance regulatory acceptance of those biomarkers for use in clinical trials.

Alto Neuroscience Faces Class Action Lawsuit Following ALTO-100 Phase 2b Trial Failure

  • Alto Neuroscience shareholders filed a class action lawsuit in Northern California federal court, alleging the company misled investors about ALTO-100's clinical prospects and biomarker-driven efficacy for major depressive disorder.
  • ALTO-100 failed its Phase 2b trial on October 22, 2024, showing no significant difference from placebo on the primary endpoint, contradicting the company's positioning of the drug as a precision psychiatry breakthrough.
  • Following the trial failure disclosure, ANRO stock crashed 69.99% on October 23, 2024, wiping out most of the value from the company's $119.6 million IPO completed just months earlier.
  • The lawsuit claims Alto concealed key clinical limitations and overstated commercialization timelines while rushing its IPO to capitalize on inflated investor expectations.

Coriolis Pharma Invests $10 Million in North Carolina Laboratory to Expand Biopharmaceutical Development Services

  • Coriolis Pharma announced a $10 million investment to establish a 13,000 square foot research laboratory at Spark LS campus in Morrisville, North Carolina, scheduled to begin operations in Q1 2026.
  • The new facility will serve as a strategic anchor for North American expansion, initially offering particle identification services followed by formulation development and lyophilization capabilities.
  • The laboratory will create 50 jobs and integrate seamlessly with Coriolis Pharma's global network while supporting future innovation including digital and in-silico technologies.
  • The investment positions the German-headquartered CRDO closer to North American clients in the Research Triangle Park region's biotechnology ecosystem.

Q3 2025 Biopharma Catalyst Monitor Highlights 18 Key FDA Decisions and Clinical Trial Milestones

Drug ApprovalRare Disease
  • A new quarterly report identifies 18 significant biopharma catalyst events expected in Q3 2025, including FDA approval decisions for multiple companies across diverse therapeutic areas.
  • Key regulatory milestones include potential approvals for Ascendis Pharma's Skytrofa for adult growth hormone deficiency, PTC Therapeutics' sepiapterin for phenylketonuria, and Lenz Therapeutics' presbyopia treatment LNZ100.
  • The report, based on key opinion leader interviews, also covers ongoing clinical trials for Eli Lilly's orforglipron for obesity and aTyr Pharma's efzofitimod for pulmonary sarcoidosis.
  • Industry experts will assess the commercial potential of these treatments and their impact on existing therapeutic landscapes across multiple disease areas.

SurgiVance Secures $2.2M NIH Grant to Advance Direct-to-Digital Pathology Platform

AIPrecision Medicine
  • SurgiVance Inc. received a $2,245,000 National Cancer Institute Small Business Innovation Research Direct-to-Phase II grant to commercialize its "pathology lab-in-a-box" technology.
  • The platform enables direct-to-digital, in-office pathology using advanced imaging hardware and AI processing on whole tissue without traditional glass microscope slides.
  • Clinical studies will be conducted at NYU Langone Health, The Rockefeller University, Northwell Health, and Oregon Health & Science University targeting cancer at cellular and molecular levels.
  • The technology promises to deliver histopathologic diagnosis in minutes, potentially transforming cancer management and precision medicine through 3D molecular imaging biomarkers.

Answer ALS Launches AI-Powered Drug Discovery Initiative to Accelerate ALS Treatment Development

AIDrug Discovery
  • Answer ALS has launched LADDIA, a groundbreaking AI-powered drug discovery collaboration with GATC Health, Pennington Biomedical Research Center, and Tulane University to accelerate ALS treatment development.
  • The initiative leverages the world's largest open-access ALS dataset through the Neuromine Data Portal and GATC Health's proprietary AI platform to identify druggable therapeutic targets.
  • Currently, there are no known viable treatments for ALS, making this AI-driven approach critical for identifying new therapeutic pathways for the neurodegenerative disease.
  • The collaboration will roll out in two phases, focusing first on building infrastructure and then activating collaborative projects to generate high-impact scientific outputs.

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